Obama Policies Reshape Pharma Marketing

Although the media coverage of Obamacare has focused on dysfunctional insurance exchanges and unworkable mandates, a number of less prominent but important health reform policies promise important changes in pharmaceutical access, coverage, and marketing. Whether it's greater transparency about pharma interactions with prescribers, new electronic information systems offering prescribing information, more comparative research on treatment options, or limitations on patient assistance programs, the common aim is to better inform prescribing — and to reduce unnecessary outlays on drugs in the process. Add to that new tax and spending plans, and pharma companies, patients, health professionals and payers face considerable challenges.

Reform impacts

An increased focus on the comparative benefits and harms posed by alternative treatments, for example, pressures marketers to provide payers, prescribers, and patients with more credible information on which therapies (including drugs) are most effective — and cost effective. The Affordable Care Act of 2010 (ACA) provides the Patient Centered Outcomes Research Institute (PCORI) with $650 million a year to fund comparative effectiveness research on the outcomes of interventions for back pain, migraine, common cancers, among other conditions, and the program promises to raise multiple challenges to conventional treatment approaches.

Another prominent initiative is to expand the use of electronic health records (EHRs) by doctors and hospitals. This may provide new opportunities for pharma companies to convey information about new drugs to prescribers, explained Mukesh Mehta, vice president of PDR Network, at a recent drug marketing conference sponsored by the Drug Information Association. The rising uptake of EHRs, Mehta explained, expands e-prescribing operations, plus programs to send out refill reminders and to check patient prescriptions, drug allergies, and drug-drug interactions. These systems carry FDA-approved prescribing information, but IT vendors are looking for ways to add on marketing messages from pharma companies.

A troubling prospect is that Obamacare could curb patient assistance programs (PAPs) offered by pharmaceutical companies to help individuals afford expensive medicines. Co-pay cards and discount programs are not allowed for Medicare and other activities defined as "federal health care programs," as the subsidies are considered "kickbacks" from manufacturers to physicians for prescribing certain drugs. Pharmacy benefit managers (PBMs) and insurers complain that such assistance programs really aim to get patients "hooked" on new, more expensive medicines and have been fighting pharma efforts to replace drug samples to physicians with various discount cards.

The question now is whether the Medicare no-pharma-assistance policy also applies to "qualified health plans" sold through the federal exchange. In response to queries from the Senate, HHS secretary Kathleen Sebelius has said that, no, exchange plans are not federal health plans. Yet, HHS also has opposed third-party support (specifically from hospitals and providers) for patient premium payments and "cost-sharing obligations" for fear that will skew the insurance risk pool. That raises questions about the legal status of PAPs.

The National Health Council has sought clarification on the issue, but the latest rule from HHS on third-party payments failed to resolve the question. Meanwhile, patient groups are pressing for continued access to pharma support, claiming that there are no low-cost alternatives to many of the newer specialty medicines. One strategy is for manufacturers to provide funds to non-profit patient organizations, which then can channel assistance to patients seeking treatment. Payers and PBMs oppose such tactics, noting that PAPs only help patients cover their copays, and insurers still have to shoulder most of the bill for the more costly medicines.